POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM

K030742 · Cryo Vascular Systems, Inc. · LIT · Aug 29, 2003 · Cardiovascular

Device Facts

• Record ID: K030742
• Device Name: POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
• Applicant: Cryo Vascular Systems, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Aug 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PolarCath Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal. infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or native arteriovenous dialysis fistulae.

Device Story

PolarCath Peripheral Balloon Catheter System is a percutaneous transluminal angioplasty (PTA) device. System components include a peripheral balloon catheter, inflation unit, connecting cable, rechargeable battery pack, and disposable liquid nitrous oxide cylinder. Device operates by delivering liquid nitrous oxide to the balloon to achieve dilation of stenotic peripheral vessels or obstructive lesions in dialysis fistulae. Used in clinical settings by physicians. Output is mechanical dilation of the target vessel/lesion. Benefits include restoration of blood flow in peripheral arteries and maintenance of dialysis access patency.

Clinical Evidence

Bench testing only. In vitro testing demonstrated that the PolarCath Peripheral Balloon Catheter System met all acceptance criteria.

Technological Characteristics

System includes peripheral balloon catheter, inflation unit, connecting cable, rechargeable battery pack, and disposable 14g liquid nitrous oxide cylinder. Operates via cryo-inflation mechanism for vessel dilation. Class II device.

Indications for Use

Indicated for patients requiring dilation of stenosis in peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal arteries) and treatment of obstructive lesions in native or synthetic (PTFE) arteriovenous dialysis fistulae.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• PolarCath Peripheral Balloon Catheter System (K030742)
• RX Viatrac 14 Peripheral Dilatation Catheter
• Vantage Dilatation Catheter
• Cook PTA Balloon Catheter

Submission Summary (Full Text)

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K030742

#### 510(k) Summary 4.

| Sponsor: | CryoVascular Systems, Inc.<br>160 Knowles Drive<br>Los Gatos, CA 95032 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kim Tompkins |
| Phone Number: | 408 866 3203 |
| Fax Number: | 408 376 3677 |
| Prepared: | March 7, 2003 |
| Trade Name: | PolarCath™ |
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Classification: | II |
| Product Code: | 79 LIT |
| Predicate Devices: | PolarCath Peripheral Balloon Catheter System<br>RX Viatrac 14 Peripheral Dilatation Catheter<br>Vantage Dilatation Catheter<br>Cook PTA Balloon Catheter |

# Device Description

The PolarCath Peripheral Balloon Catheter System consists of a Peripheral Balloon Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cylinder.

## Indications for Use

The PolarCath Peripheral Balloon Catheter System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

#### Substantial Equivalence

The PolarCath Peripheral Balloon Catheter System design, materials, manufacturing process and intended use are substantially equivalent to the predicate devices.

## Performance Data

In vitro testing demonstrated that the PolarCath Peripheral Balloon Catheter System met all acceptance criteria.

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AUG 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CryoVascular Systems, Inc. c/o Ms. KimTompkins Regulatory Affairs 160 Knowles Drive Los Gatos, CA 95032

Re: K030742

Trade Name: PolarCath™ Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT Dated: June 9, 2003 Received: June 10, 2003

Dear Ms. Tompkins:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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#### Page 2 - Ms. KimTompkins

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Jlos. OHAz fr

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K030742

Device Name: PolarCath™ Peripheral Dilatation System

Indications for Use:

The PolarCath Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal. infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or native arteriovenous dialysis fistulae.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Optional Format 3-10-98)

(Posted July 1, 1998)

510(k) Number K030742

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